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| Name | Class |
|---|---|
| Viewray Inc. | INDUSTRY |
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The purpose of the study is to utilize radiomic images to precisely locate areas of tumor that can be treated with dose escalation radiation therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Participants will receive pretreatment diagnostic MRIs to generate MRI habitats (images of tumor regions/subregions in different sequences). These images will identify radioresistant cells within the tumor to allow for more precise and higher doses of radiation to the resistant cells. Participants will then be treated with neoadjuvant external beam radiation by using the intensity modulated radiation (IMRT) technique, with dose painting (simultaneous integrated boost/SIB) to 70 Gray Units (Gy), 60 Gy, and 50 Gy in 25 fractions for habitats 1, 2, and 3, respectively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensity Modulated Radiation Therapy (IMRT) | Radiation | Participants will be treated with intensity modulated radiation therapy (IMRT) with photons, which is FDA (U.S. Food and Drug Administration) approved radiation delivery system. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Favorable Pathologic Response (FPR) | Percentage of participants with Favorable Pathologic Response (FPR): tumor necrosis >/= 95% at time of surgery. FPR is associated with improved R0 resection rates, local control, distant control, and overall survival. Therefore, FPR acts as an early surrogate for outcome. | Week 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of tumor with clear margin and positive margin | Review of final tumor margin of the surgical specimen, defined as tumor at ink margin, will be conducted by pathologist. A clear margin (R0) or a positive margin (R1/R2) will be designated, along with the location of the margin, which will be radiographically correlated to the habitat . Surgical margins are independent predictors for local control. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate | Disease control rate defined as the sum of complete response, partial response, and stable disease rates. | Up to 6 months |
| Overall Survival | Overall Survival defined as the time from date of initial treatment to date of death. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Inaya Lemus | Contact | 813-745-4233 | Inaya.Lemus@moffitt.org |
| Name | Affiliation | Role |
|---|---|---|
| Arash O Naghavi, MD, MS | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Recruiting | Tampa | Florida | 33612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38594603 | Derived | Naghavi AO, Bryant JM, Kim Y, Weygand J, Redler G, Sim AJ, Miller J, Coucoules K, Michael LT, Gloria WE, Yang G, Rosenberg SA, Ahmed K, Bui MM, Henderson-Jackson EB, Lee A, Lee CD, Gonzalez RJ, Feygelman V, Eschrich SA, Scott JG, Torres-Roca J, Latifi K, Parikh N, Costello J. Habitat escalated adaptive therapy (HEAT): a phase 2 trial utilizing radiomic habitat-directed and genomic-adjusted radiation dose (GARD) optimization for high-grade soft tissue sarcoma. BMC Cancer. 2024 Apr 9;24(1):437. doi: 10.1186/s12885-024-12151-7. |
| Label | URL |
|---|---|
| Moffitt Cancer Center Clinical Trials website | View source |
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| ID | Term |
|---|---|
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| MRI | Diagnostic Test | Participants will receive pretreatment diagnostic MRIs to generate MRI habitats. These images will identify radioresistant cells within tumor. |
|
| Weeks 10-13 |
| Up to 8 months |